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Quality-of-life results for accelerated partial breast irradiation with interstitial brachytherapy versus whole-breast irradiation in early breast cancer after breast-conserving surgery (GEC-ESTRO): 5-year results of a randomised, phase 3 trial.
Schäfer, Rebekka; Strnad, Vratislav; Polgár, Csaba; Uter, Wolfgang; Hildebrandt, Guido; Ott, Oliver J; Kauer-Dorner, Daniela; Knauerhase, Hellen; Major, Tibor; Lyczek, Jaroslaw; Guinot, Jose Luis; Dunst, Jürgen; Miguelez, Cristina Gutierrez; Slampa, Pavel; Allgäuer, Michael; Lössl, Kristina; Kovács, György; Fischedick, Arnt-René; Fietkau, Rainer; Resch, Alexandra; Kulik, Anna; Arribas, Leo; Niehoff, Peter; Guedea, Ferran; Schlamann, Annika; Gall, Christine; Polat, Bülent.
Afiliación
  • Schäfer R; Department of Radiation Oncology, University Hospital Würzburg, Würzburg, Germany. Electronic address: schaefer_r2@ukw.de.
  • Strnad V; Department of Radiation Oncology, University Hospital Erlangen, Erlangen, Germany.
  • Polgár C; Center of Radiotherapy, National Institute of Oncology, Budapest, Hungary; Department of Oncology, Semmelweis University, Budapest, Hungary.
  • Uter W; Department of Medical Informatics, Biometry and Epidemiology, University Erlangen-Nuremberg, Erlangen, Germany.
  • Hildebrandt G; Department of Radiation Oncology, University Hospital Leipzig, Leipzig, Germany; Department of Radiation Oncology, University Hospital Rostock, Rostock, Germany.
  • Ott OJ; Department of Radiation Oncology, University Hospital Erlangen, Erlangen, Germany.
  • Kauer-Dorner D; Department of Radiation Oncology, University Hospital AKH Wien, Vienna, Austria.
  • Knauerhase H; Department of Radiation Oncology, University Hospital Rostock, Rostock, Germany.
  • Major T; Center of Radiotherapy, National Institute of Oncology, Budapest, Hungary.
  • Lyczek J; Podkarpacki Hospital Cancer Center Brzozow, Brzozow, Poland; Brachytherapy Department, Centrum Onkologii-Instytut im Marii Sklodowskiej, Warsaw, Poland.
  • Guinot JL; Department of Radiation Oncology, Valencian Institute of Oncology, Valencia, Spain.
  • Dunst J; Department of Radiation Oncology, University Hospital Kiel, Kiel, Germany.
  • Miguelez CG; Department of Radiation Oncology, Catalan Institute of Oncology, Barcelona, Spain.
  • Slampa P; Department of Radiation Oncology, Masaryk Memorial Cancer Institute and Faculty of Medicine, Brno, Czech Republic.
  • Allgäuer M; Department of Radiation Oncology, Hospital Barmherzige Brüder, Regensburg, Germany.
  • Lössl K; Department of Radiation Oncology, University Hospital Bern, Inselspital, Switzerland.
  • Kovács G; Interdisciplinary Brachytherapy Unit, University of Lubeck/Universitätsklinikum Schleswig-Holstein Campus Lubeck, Lubeck, Germany.
  • Fischedick AR; Department of Radiation Oncology, Clemens Hospital, Münster, Germany.
  • Fietkau R; Department of Radiation Oncology, University Hospital Erlangen, Erlangen, Germany; Department of Radiation Oncology, University Hospital Rostock, Rostock, Germany.
  • Resch A; Department of Radiation Oncology, University Hospital AKH Wien, Vienna, Austria.
  • Kulik A; Brachytherapy Department, Centrum Onkologii-Instytut im Marii Sklodowskiej, Warsaw, Poland.
  • Arribas L; Department of Radiation Oncology, Valencian Institute of Oncology, Valencia, Spain.
  • Niehoff P; Department of Radiation Oncology, University Hospital Kiel, Kiel, Germany; Department of Radiotherapy, Sana Hospital Offenbach, Offenbach, Germany.
  • Guedea F; Department of Radiation Oncology, Catalan Institute of Oncology, Barcelona, Spain.
  • Schlamann A; Department of Radiation Oncology, University Hospital Leipzig, Leipzig, Germany.
  • Gall C; Department of Medical Informatics, Biometry and Epidemiology, University Erlangen-Nuremberg, Erlangen, Germany.
  • Polat B; Department of Radiation Oncology, University Hospital Würzburg, Würzburg, Germany.
Lancet Oncol ; 19(6): 834-844, 2018 06.
Article en En | MEDLINE | ID: mdl-29695348
BACKGROUND: Previous results from the GEC-ESTRO trial showed that accelerated partial breast irradiation (APBI) using multicatheter brachytherapy in the treatment of early breast cancer after breast-conserving surgery was non-inferior to whole-breast irradiation in terms of local control and overall survival. Here, we present 5-year results of patient-reported quality of life. METHODS: We did this randomised controlled phase 3 trial at 16 hospitals and medical centres in seven European countries. Patients aged 40 years or older with 0-IIA breast cancer were randomly assigned (1:1) after breast-conserving surgery (resection margins ≥2 mm) to receive either whole-breast irradiation of 50 Gy with a boost of 10 Gy or APBI using multicatheter brachytherapy. Randomisation was stratified by study centre, tumour type, and menopausal status, with a block size of ten and an automated dynamic algorithm. There was no masking of patients or investigators. The primary endpoint of the trial was ipsilateral local recurrence. Here, we present 5-year results of quality of life (a prespecified secondary endpoint). Quality-of-life questionnaires (European Organisation for Research and Treatment of Cancer QLQ-C30, breast cancer module QLQ-BR23) were completed before radiotherapy (baseline 1), immediately after radiotherapy (baseline 2), and during follow-up. We analysed the data according to treatment received (as-treated population). Recruitment was completed in 2009, and long-term follow-up is continuing. The trial is registered at ClinicalTrials.gov, number NCT00402519. FINDINGS: Between April 20, 2004, and July 30, 2009, 633 patients had accelerated partial breast irradiation and 551 patients had whole-breast irradiation. Quality-of-life questionnaires at baseline 1 were available for 334 (53%) of 663 patients in the APBI group and 314 (57%) of 551 patients in the whole-breast irradiation group; the response rate was similar during follow-up. Global health status (range 0-100) was stable in both groups: at baseline 1, APBI group mean score 65·5 (SD 20·6) versus whole-breast irradiation group 64·6 (19·6), p=0·37; at 5 years, APBI group 66·2 (22·2) versus whole-breast irradiation group 66·0 (21·8), p=0·94. The only moderate, significant difference (difference of 10-20 points) between the groups was found in the breast symptoms scale. Breast symptom scores were significantly higher (ie, worse) after whole-breast irradiation than after APBI at baseline 2 (difference of means 13·6, 95% CI 9·7-17·5; p<0·0001) and at 3-month follow-up (difference of means 12·7, 95% CI 9·8-15·6; p<0·0001). INTERPRETATION: APBI with multicatheter brachytherapy was not associated with worse quality of life compared with whole-breast irradiation. This finding supports APBI as an alternative treatment option after breast-conserving surgery for patients with early breast cancer. FUNDING: German Cancer Aid.
Asunto(s)

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Calidad de Vida / Braquiterapia / Neoplasias de la Mama / Carcinoma / Mastectomía Segmentaria Tipo de estudio: Clinical_trials Aspecto: Patient_preference Límite: Adult / Aged / Female / Humans / Middle aged País/Región como asunto: Europa Idioma: En Revista: Lancet Oncol Asunto de la revista: NEOPLASIAS Año: 2018 Tipo del documento: Article Pais de publicación: Reino Unido

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Calidad de Vida / Braquiterapia / Neoplasias de la Mama / Carcinoma / Mastectomía Segmentaria Tipo de estudio: Clinical_trials Aspecto: Patient_preference Límite: Adult / Aged / Female / Humans / Middle aged País/Región como asunto: Europa Idioma: En Revista: Lancet Oncol Asunto de la revista: NEOPLASIAS Año: 2018 Tipo del documento: Article Pais de publicación: Reino Unido